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Effective respiratory ventilation is achieved by moving the right amount of air to and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.
Poor manual ventilation technique is a well-documented problem which occurs irrespective of a provider's qualifications or experience. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery among providers. The device is attached to a bag valve mask (i.e. manual resuscitator) and employs a flow limiting valve mechanism to minimize excessive pressure in the airway system without venting air by capping peak flow rates at 55 L/min. For an average adult with normal lung compliance and resistance, this corresponds to a maximum airway pressure of approximately 20 cmH2O which minimizes air entry into the stomach. In this superiority study, the investigators will use a two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone with respect to airway pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bag mask ventilation with Adult Sotair device | Active Comparator | The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds. |
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| Bag mask ventilation | No Intervention | The anesthesia provider will manually bag ventilate for 3 minutes with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adult Sotair Device | Device | Adult Sotair® device employs a flow limiting valve mechanism. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak airway pressure | Mean of the maximum peak airway pressures expressed in cm H2O | Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Tidal volume | The amount of air that moves to or out of the lungs with each respiratory cycle. Measured in mL. Mean of the maximum tidal volumes every 30 seconds. | Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study |
| Airflow |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Kendall, MD | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31338661 | Background | Fogarty M, Kuck K, Orr J, Sakata D. A comparison of controlled ventilation with a noninvasive ventilator versus traditional mask ventilation. J Clin Monit Comput. 2020 Aug;34(4):771-777. doi: 10.1007/s10877-019-00365-1. Epub 2019 Jul 23. | |
| 15733761 | Background | von Goedecke A, Bowden K, Wenzel V, Keller C, Gabrielli A. Effects of decreasing inspiratory times during simulated bag-valve-mask ventilation. Resuscitation. 2005 Mar;64(3):321-5. doi: 10.1016/j.resuscitation.2004.09.003. |
| Label | URL |
|---|---|
| Adult Sotair Products | View source |
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The IPD that underlie the results in a publication will be shared with other researchers.
The SAP will be available at the end of the trial for three years. The data that supports the findings of the study will be available form the corresponding investigator upon reasonable request.
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Study Design: A superiority trial; a single two-group cross over randomized trial.
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The care provider will not know the recorded lung function recordings.
Represents the volume of air moved per unit of time during inspiration and expiration. Measured (L/min) |
| Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study |
| 33138977 | Background | Culbreth RE, Gardenhire DS. Manual bag valve mask ventilation performance among respiratory therapists. Heart Lung. 2021 May-Jun;50(3):471-475. doi: 10.1016/j.hrtlng.2020.10.012. Epub 2020 Nov 1. |